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TESARO ANNOUNCES SECOND-QUARTER 2017 OPERATING RESULTS
· ZEJULA is the most prescribed PARP inhibitor in U.S.; Q2 net sales totaled $26 million in first quarter of availability
· Recently opened European niraparib EAP has enrolled 200 patients
· VARUBY oral launch now underway in Europe
· Dose-escalation of TSR-022 (anti-TIM-3) completed and combination trial with TSR-042 (anti-PD-1) initiated
· Regulatory strategy defined with FDA for TSR-042 in MSI-high cancers and registration study ongoing
· License agreement signed with Takeda in July for niraparib development and commercialization in Japan and certain other countries with a $100 million upfront payment and up to $240 million in milestones
WALTHAM, Mass., August 8, 2017 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today reported operating results for second-quarter 2017 and provided an update on the Companys commercial products and development programs.
The U.S. launch of ZEJULA, the first and only PARP inhibitor to be approved for the maintenance treatment of women with recurrent ovarian cancer, regardless of BRCA mutation or biomarker status, is off to an excellent start, and we are gratified by the positive feedback that we have received from patients and prescribers, said Lonnie Moulder, CEO of TESARO. Following its introduction in late April, ZEJULA quickly became the most frequently prescribed PARP inhibitor in the U.S. The MAA for ZEJULA is under review in Europe, and we are pleased that interest in our expanded access program (EAP) has been high, as we anticipate the European launch of ZEJULA by year end. We continue to globalize our mission with the recently announced Takeda licensing agreement for ZEJULA in Japan, and the launches of VARUBY oral in several EU countries. We are advancing the registration program for TSR-042, our anti-PD-1 antibody, and have initiated a combination clinical study of our anti-TIM-3 antibody, TSR-022, plus TSR-042. We are also pleased with the progress of our earlier stage immuno-oncology antibody and small molecule programs and the potential for this pipeline to establish TESARO as a leading player in the field.
Recent Business Highlights
· TESARO launched ZEJULA in the U.S. in April 2017, following U.S. Food and Drug Administration (FDA) approval for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum-based chemotherapy. ZEJULA is the most prescribed PARP inhibitor in the U.S., with more than 1,500 new patients treated in the second quarter and prescriptions written by over 1,000 physicians since launch.
The following information was filed by Tesaro, Inc. (TSRO) on Tuesday, August 8, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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